In order to reduce the risks and recovery time associated with surgery, medical professionals have developed minimally invasive surgical procedures such as laparoscopy. During laparoscopy, a small incision is made in the patient's abdominal wall. Various surgical instruments are then partially inserted through the incision for use inside the abdominal cavity. For instance, laparoscopic procedures may be used in examining the female reproductive organs, in performing surgical procedures such as tumor removal and sterilization, and in collecting ova for in vitro fertilization.
However, the position of the patient's uterus may cause serious difficulties during such minimally invasive medical procedures. For instance, the uterus may obstruct the physician's view of the interior of the abdominal cavity, making it difficult or impossible to examine the uterus and other internal organs as needed. Moreover, the position of the uterus may interfere with surgical procedures by hindering the surgeon's access to the surgical site.
Various existing devices permit manipulation of the uterus during medical procedures. One uterine positioning device is denoted herein the "two-handed tenaculum manipulator," for reasons which will become apparent. The two-handed tenaculum manipulator includes a rigid bar and a rigid tube that are each pivotally connected at one end to a head. A rigid finger is also attached to the head, in the same plane as the bar and tube but at a right angle to them. The opposite ends of the bar and tube are pivotally connected to a spacer. The bar, tube, spacer, and head are thus connected in a parallelogram whose angles may be changed. By pivoting the spacer relative to the tube and the bar, one may pivot the head. Pivoting the head also moves the finger which is attached to the head. A locking screw is provided on the spacer for locking the spacer, tube, and bar into a selected position relative to one another.
In operation, the finger is inserted through the patient's vagina and cervix into the uterus, with the device's head pressing against the entrance to the cervix. A sharp wire hook with a handle, known collectively as a "tenaculum," is used to hook part of the cervix. The handle end of the tenaculum is then secured to a spring-loaded holder on the device's bar to maintain enough pressure on the device's head to keep the finger inside the uterus. A portion of the tube and bar are located inside the patient's vagina and cervix, while the spacer remains outside the patient.
Once the two-handed tenaculum manipulator is positioned in the uterus and secured by a tenaculum, movements of the spacer by the surgeon translate into movements of the finger, which in turn permit the surgeon to rotate the uterus about an anteverting axis and a cervical axis of rotation. The cervical axis is aligned with the patient's cervical passage. The anteverting axis is perpendicular to the cervical axis. By moving the spacer the surgeon may antevert the uterus, rotating it forward away from the spine. Conversely, the surgeon may retrovert the uterus, moving it back toward the spine. By locking the spacer in position and rotating the device about the longitudinal axis of the bar and tube, the surgeon may rotate the uterus to the left or right in an arc about the cervical axis.
The two-handed tenaculum manipulator may also be used to insert dyes, irrigation rinses, or other fluids into the uterus. A syringe or other source of fluid is attached to the external end of the tube. The finger is equipped with a conduit which communicates with the internal end of the tube, and with an opening at the tip of the finger.
In use, however, the two-handed tenaculum manipulator has several drawbacks. First, the use of a tenaculum to hold the device in place requires not merely puncturing the patient's internal tissue but also aggravating that injury by leaving the tenaculum hook in place and pulling on the hook. Even if the cervical tissue is "merely" clamped and pulled rather than being punctured, the resulting injury adds to the risks faced by the patient and often increases the patient's recovery period.
Another drawback of such a device is the lack of a convenient handle for holding and positioning the device. The two-handed tenaculum manipulator contains no grip which permits the surgeon to easily and reliably position the spacer relative to the tube and bar. At least two hands are needed to maintain control of the device's position, particularly if the device is covered with blood or other slippery fluids.
A further drawback, which becomes apparent once the spacer is positioned, is the need to use at least two hands to lock the finger in position about the anteverting axis. One hand is required to hold the spacer in the desired position relative to the tube while another hand tightens the locking screw. However, a surgeon often needs to hold at least two instruments at the same time. For example, the surgeon may need to hold a laparo-scope in place to ensure that the uterus remains in the desired position while the manipulator screw is tightened. Additional carefully coordinated assistance is then required because the surgeon cannot simultaneously lock the manipulator in position and hold the laparoscope in place.
An additional drawback of this device is its metal construction. Although exceptionally strong and rigid, the metal is electrically conductive and optically reflective. The device therefore has limited usefulness during electrosurgical or laser procedures.
Moreover, the two-handed tenaculum manipulator is expensive, so it must be reused. Before reuse, the device must be cleaned and sterilized. However, the complexity of the device makes it difficult and costly to clean.
A different uterine positioning device includes a curved rigid handle which contains a catheter. One end of the handle is inserted into the uterus until a stop on the handle abuts the vaginal side of the cervix. A balloon on the inserted end of the handle is then inflated against the uterine side of the cervix. Like the two-handed tenaculum manipulator, the curved handle device may be rotated to left or right to rotate the uterus about the cervical axis of rotation. One positive feature of such a curved handle device is its replacement of the tenaculum by the less traumatic stop and balloon combination.
A drawback of the curved handle device, however, is that it has no structure corresponding to the rotatable finger of the two-handed tenaculum manipulator. As a result, the degree to which the curved handle device may be used in anteverting or retroverting a uterus is extremely limited. When the curved handle device is initially inserted, one end of the device resides inside the uterus and another portion of the device is approximately centered within the patient's vaginal canal. Immediately after insertion, the angle of the uterus relative to the vaginal canal is therefore defined substantially by the degree of curvature of the device's handle. However, the handle curvature is fixed and the device lacks a rotatable finger. Thus, the uterus can be easily anteverted or retroverted away from this initial angle only by pressing the handle of the device against the vaginal canal. However, pressing the handle firmly against the vaginal tissue to alter the uterus' position may cause substantial injury to the vaginal tissue. The vaginal opening is particularly susceptible to rips or bruises caused in this manner. Moreover, the injury may be exacerbated if the pressure is sustained for any length of time while maintaining the uterus in the altered position.
Another drawback of the curved handle device is the lack of a convenient handle for holding and positioning the device. Like the two-handed tenaculum manipulator, the curved handle device contains no secure and comfortable grip which permits the surgeon to easily and reliably position the device. Positioning is particularly difficult along the curved longitudinal axis of the device.
Thus, it would be an advancement in the art to provide a uterine manipulator that is capable of maintaining its position relative to the uterus without hooking a tenaculum into the patient.
It would also be an advancement to provide a uterine manipulator that provides a reliable single-handed grip for positioning the manipulator to thereby position the uterus.
It would be a related advancement to provide a uterine manipulator capable of rotating the uterus about the cervical axis and also capable of rotating the uterus about the anteverting axis.
It would be a further advancement to provide a uterine manipulator which can be locked with one hand, thereby holding the uterus in a selected position about the anteverting axis.
It would be an additional advancement to provide such a uterine manipulator which is constructed almost entirely of nonconductive and nonreflective plastic.
It would also be an advancement to provide such a uterine manipulator which is designed and constructed so as to be a single use, disposable manipulator.
It would be a further advantage to provide such a uterine manipulator which is capable of introducing fluids into the uterus.
Such a uterine manipulator is disclosed and claimed herein.